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    Clinical Trial Results:
    A double blind, randomized, placebo controlled phase II study to assess the efficacy of recPRAME +AS15 Antigen-Specific Cancer Immunotherapeutic as adjuvant therapy in patients with resected PRAME-positive, Non-Small Cell Lung Cancer

    Summary
    EudraCT number
    		 2012-002790-55
    Trial protocol
    		 EE   GB   DE  
    Global end of trial date
    24 Aug 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Aug 2017
    First version publication date
    30 Aug 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    116389
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01853878
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Feb 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Aug 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the clinical efficacy of the recPRAME versus placebo in terms of disease-free survival (DFS)
    Protection of trial subjects
    All subjects were supervised after vaccination/product administration with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 May 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Estonia: 63
    Country: Number of subjects enrolled
    France: 40
    Country: Number of subjects enrolled
    Germany: 131
    Country: Number of subjects enrolled
    Japan: 123
    Country: Number of subjects enrolled
    Korea, Republic of: 33
    Country: Number of subjects enrolled
    Poland: 16
    Country: Number of subjects enrolled
    Russian Federation: 64
    Country: Number of subjects enrolled
    United Kingdom: 115
    Country: Number of subjects enrolled
    United States: 96
    Worldwide total number of subjects
    681
    EEA total number of subjects
    365
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    294
    From 65 to 84 years
    381
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Am ong 681 enrolled patients, 358 were reported with positive PRAME expression results (out of whom 221 patients were not randomized for screening failures reasons) and 4 patients didn’t receive any study product dose.

    Pre-assignment period milestones
    Number of subjects started
    		 681
    Number of subjects completed
    		 133

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 No treatment received: 4
    Reason: Number of subjects
    		 positive PRAME expression results: 358
    Reason: Number of subjects
    		 Unspecified: 186
    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GSK2302032A Group
    Arm description
    		 The patients received 13 administrations of the GSK2302032A product, as per the following schedule: For the first five doses: 1 dose every 3 weeks. For the remaining 8 doses: 1 dose every 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    recPRAME + AS15 Antigen-Specific Cancer Immunotherapeutic
    Investigational medicinal product code
    PRAME ASCI
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The patients received 13 administrations of the product, as per the following schedule: For the first five doses: 1 dose every 3 weeks. For the remaining 8 doses: 1 dose every 12 weeks.

    Arm title
    		 Placebo group
    Arm description
    		 The patients received 13 administrations of a placebo, as per the following schedule: For the first five doses: 1 dose every 3 weeks. For the remaining 8 doses: 1 dose every 12 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The patients received 13 administrations of the product, as per the following schedule: For the first five doses: 1 dose every 3 weeks. For the remaining 8 doses: 1 dose every 12 weeks.

    Number of subjects in period 1 [1]
    		GSK2302032A Group Placebo group
    Started
    86
    47
    Completed
    23
    3
    Not completed
    63
    44
         Migrated/moved from the study area
    1
    -
         Consent withdrawn by subject
    3
    1
         Adverse event, non-fatal
    2
    -
         Unspecified
    55
    43
         Recurrence
    2
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Am ong 681 enrolled patients, 358 were reported with positive PRAME expression results (out of whom 221 patients were not randomized for screening failures reasons) and 4 patients didn’t receive any study product dose.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK2302032A Group
    Reporting group description
    		 The patients received 13 administrations of the GSK2302032A product, as per the following schedule: For the first five doses: 1 dose every 3 weeks. For the remaining 8 doses: 1 dose every 12 weeks.

    Reporting group title
    Placebo group
    Reporting group description
    		 The patients received 13 administrations of a placebo, as per the following schedule: For the first five doses: 1 dose every 3 weeks. For the remaining 8 doses: 1 dose every 12 weeks.

    Reporting group values
    		 GSK2302032A Group Placebo group Total
    Number of subjects
    		 86 47
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.5 ± 8.68 62.7 ± 9.28 -
    Gender categorical
    Units: Subjects
        Female
    		 26 13 39
        Male
    		 60 34 94

    End points

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    End points reporting groups
    Reporting group title
    GSK2302032A Group
    Reporting group description
    		 The patients received 13 administrations of the GSK2302032A product, as per the following schedule: For the first five doses: 1 dose every 3 weeks. For the remaining 8 doses: 1 dose every 12 weeks.

    Reporting group title
    Placebo group
    Reporting group description
    		 The patients received 13 administrations of a placebo, as per the following schedule: For the first five doses: 1 dose every 3 weeks. For the remaining 8 doses: 1 dose every 12 weeks.

    Primary: Time to occurrence of any recurrence of disease

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    End point title
    		 Time to occurrence of any recurrence of disease
    End point description
    Time to occurrence of any recurrence of disease is expressed in terms of rate: Person-year rate in each group = number of patients reporting at least one recurrence of disease (n)/ sum of follow-up period expressed in years (T[year)]) As a consequence of the decision to stop the PRAME-AS15-NSC-002 (ADJ) study, not all data were available for a full analysis. The median follow-up time was 10.3 months in the GSK2302032A group and 5.7 months in the Placebo group.
    End point type
    Primary
    End point timeframe
    During the entire study (From Week 1 to Week 112)
    End point values
    		 GSK2302032A Group Placebo group
    Number of subjects analysed
    86
    47
    Units: Months
    number (not applicable)
        Months
    82.86
    14.93
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Estimates of Hazard Ratio (HR) and their 95% Confidence Interval (CI) were obtained by Cox regression modelling.The Likelihood ratio test was used to compare the groups. The Cox proportional hazard regression was stratified by previous treatment (CT vs. no-CT) and disease stage.
    Comparison groups
    Placebo group v GSK2302032A Group
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    P-value
    		 = 0.1422
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    4.492
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 35.167
    Notes
    [1] - P-value of the Wald test from a Cox regression model to test H0 = { HR=1} (Y = Time to Event)

    Secondary: Number of patients with any Adverse Events

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    End point title
    		 Number of patients with any Adverse Events
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
    End point type
    Secondary
    End point timeframe
    Up to 30 days post last dose of study product administration
    End point values
    		 GSK2302032A Group Placebo group
    Number of subjects analysed
    86
    47
    Units: Participants
        Participants
    78
    21
    No statistical analyses for this end point

    Secondary: Number of patients with any abnormal hematological and biochemical parameters

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    End point title
    		 Number of patients with any abnormal hematological and biochemical parameters
    End point description
    Hematological and biochemical parameters assessed were tabulated by maximum grade versus baseline, by CTC = Common Terminology Criteria and by the type of abnormality (e.g. inrcreased, decreased, prolonged, etc.). Some parameters (e.g. Anemia) already comprise within their defintion the type of abnormality presented. Due to character constraints, some parameteres were abbreviated as follows: Activated partial thromboplastin=APT; Alanine aminotransferase=ALT.
    End point type
    Secondary
    End point timeframe
    For the whole study duration (Day 0 to Week 112)
    End point values
    		 GSK2302032A Group Placebo group
    Number of subjects analysed
    86
    47
    Units: Participants
        APT time prolonged Grade 1
    26
    8
        APT time prolonged Grade 2
    1
    0
        APT time prolonged Grade 3
    0
    0
        APT time prolonged Grade 4
    0
    0
        APT time prolonged Grade 5
    0
    0
        APT prolonged Unknown
    1
    2
        ALT increased Grade 1
    17
    6
        ALT increased Grade 2
    1
    0
        ALT increased Grade 3
    0
    0
        ALT increased Grade 4
    0
    0
        ALT increased Grade 5
    0
    0
        ALT increased Unknown
    0
    1
        Alkaline Phosphatase increased Grade 1
    17
    5
        Alkaline Phosphatase increased Grade 2
    0
    0
        Alkaline Phosphatase increased Grade 3
    0
    0
        Alkaline Phosphatase increased Grade 4
    0
    0
        Alkaline Phosphatase increased Grade 5
    0
    0
        Alkaline Phosphatase increased Unknown
    0
    1
        Anemia Grade 1
    36
    17
        Anemia Grade 2
    0
    2
        Anemia Grade 3
    0
    0
        Anemia Grade 4
    0
    0
        Anemia Grade 5
    0
    0
        Anemia Unknown
    1
    1
        Aspartate aminotransferase increased Grade 1
    15
    5
        Aspartate aminotransferase increased Grade 2
    0
    0
        Aspartate aminotransferase increased Grade 3
    0
    0
        Aspartate aminotransferase increased Grade 4
    0
    0
        Aspartate aminotransferase increased Grade 5
    0
    0
        Aspartate aminotransferase increased Unknown
    0
    1
        Blood bilirubin increased Grade 1
    7
    2
        Blood bilirubin increased Grade 2
    1
    1
        Blood bilirubin increased Grade 3
    0
    0
        Blood bilirubin increased Grade 4
    0
    0
        Blood bilirubin increased Grade 5
    0
    0
        Blood bilirubin increased Unknown
    0
    1
        Creatinine increased Grade 1
    15
    7
        Creatinine increased Grade 2
    3
    0
        Creatinine increased Grade 3
    0
    0
        Creatinine increased Grade 4
    0
    0
        Creatinine increased Grade 5
    0
    0
        Creatinine increased Unknown
    0
    1
        Gamma-glutamyl transferase increased Grade 1
    14
    11
        Gamma-glutamyl transferase increased Grade 2
    7
    1
        Gamma-glutamyl transferase increased Grade 3
    2
    0
        Gamma-glutamyl transferase increased Grade 4
    0
    0
        Gamma-glutamyl transferase increased Grade 5
    0
    0
        Gamma-glutamyl transferase increased Unknown
    0
    2
        Hemoglobin increased Grade 1
    5
    1
        Hemoglobin increased Grade 2
    1
    0
        Hemoglobin increased Grade 3
    0
    0
        Hemoglobin increased Grade 4
    0
    0
        Hemoglobin increased Grade 5
    0
    0
        Hemoglobin increased Unknown
    0
    1
        Hyperkalemia Grade 1
    22
    12
        Hyperkalemia Grade 2
    4
    1
        Hyperkalemia Grade 3
    1
    0
        Hyperkalemia Grade 4
    0
    0
        Hyperkalemia Grade 5
    0
    0
        Hyperkalemia Unknown
    0
    1
        Hypernatremia Grade 1
    13
    6
        Hypernatremia Grade 2
    4
    1
        Hypernatremia Grade 3
    0
    0
        Hypernatremia Grade 4
    0
    0
        Hypernatremia Grade 5
    0
    0
        Hypernatremia Unknown
    0
    1
        Hypoalbuminemia Grade 1
    18
    10
        Hypoalbuminemia Grade 2
    3
    0
        Hypoalbuminemia Grade 3
    0
    0
        Hypoalbuminemia Grade 4
    0
    0
        Hypoalbuminemia Grade 5
    0
    0
        Hypoalbuminemia Unknown
    0
    2
        Hypokalemia Grade 1
    3
    1
        Hypokalemia Grade 2
    0
    0
        Hypokalemia Grade 3
    0
    0
        Hypokalemia Grade 4
    0
    0
        Hypokalemia Grade 5
    0
    0
        Hypokalemia Unknown
    0
    1
        Hyponatremia Grade 1
    10
    6
        Hyponatremia Grade 2
    0
    0
        Hyponatremia Grade 3
    1
    0
        Hyponatremia Grade 4
    0
    0
        Hyponatremia Grade 5
    0
    0
        Hyponatremia Unknown
    0
    1
        Lymphocyte count decreased Grade 1
    19
    8
        Lymphocyte count decreased Grade 2
    3
    2
        Lymphocyte count decreased Grade 3
    2
    0
        Lymphocyte count decreased Grade 4
    0
    0
        Lymphocyte count decreased Grade 5
    0
    0
        Lymphocyte count decreased Unknown
    0
    1
        Lymphocyte count increased Grade 1
    0
    0
        Lymphocyte count increased Grade 2
    2
    0
        Lymphocyte count increased Grade 3
    0
    0
        Lymphocyte count increased Grade 4
    0
    0
        Lymphocyte count increased Grade 5
    0
    0
        Lymphocyte count increased Unknown
    0
    1
        Neutrophil count decreased Grade 1
    9
    7
        Neutrophil count decreased Grade 2
    4
    1
        Neutrophil count decreased Grade 3
    0
    0
        Neutrophil count decreased Grade 4
    0
    0
        Neutrophil count decreased Grade 5
    0
    0
        Neutrophil count decreased Unknown
    0
    1
        Platelet count decreased Grade 1
    6
    1
        Platelet count decreased Grade 2
    1
    0
        Platelet count decreased Grade 3
    0
    0
        Platelet count decreased Grade 4
    0
    0
        Platelet count decreased Grade 5
    0
    0
        Platelet count decreased Unknown
    0
    1
        White blood cell decreased Grade 1
    7
    4
        White blood cell decreased Grade 2
    1
    0
        White blood cell decreased Grade 3
    0
    0
        White blood cell decreased Grade 4
    0
    0
        White blood cell decreased Grade 5
    0
    0
        White blood cell decreased Unknown
    0
    1
    No statistical analyses for this end point

    Secondary: Occurrence of Serious Adverse Events (SAEs)

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    End point title
    		 Occurrence of Serious Adverse Events (SAEs)
    End point description
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. An event that was part of the natural course of the disease under study (i.e., disease progression, recurrence) was captured in the study as an efficacy measure; therefore it did not need to be reported as an SAE.
    End point type
    Secondary
    End point timeframe
    During the entire study (From Week 1 to Week 112)
    End point values
    		 GSK2302032A Group Placebo group
    Number of subjects analysed
    86
    47
    Units: Participants
        Participants
    14
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Unsolicited adverse events: 30 days post study treatment administration. Serious adverse events (SAEs): throughout the study (i.e. up to Week 112).
    Adverse event reporting additional description
    An event that was part of the natural course of the disease under study (i.e., disease progression, recurrence) was captured in the study as an efficacy measure; therefore it did not need to be reported as an SAE.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    GSK2302032A Group
    Reporting group description
    		 The patients received 13 administrations GSK2302032A product, as per the following schedule: For the first five doses: 1 dose every 3 weeks. For the remaining 8 doses: 1 dose every 12 weeks.

    Reporting group title
    Placebo group
    Reporting group description
    		 The patients received 13 administrations of a placebo, as per the following schedule: For the first five doses: 1 dose every 3 weeks. For the remaining 8 doses: 1 dose every 12 weeks.

    Serious adverse events
    		 GSK2302032A Group Placebo group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 86 (16.28%)
    0 / 47 (0.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Peripheral swelling
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary artery thrombosis
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Large intestine polyp
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Actinic keratosis
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Enterocolitis infectious
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemorrhagic pneumonia
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2.13%
    Non-serious adverse events
    		 GSK2302032A Group Placebo group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    78 / 86 (90.70%)
    21 / 47 (44.68%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 86 (4.65%)
    3 / 47 (6.38%)
         occurrences all number
    4
    3
    Cardiac disorders
    Pericardial effusion
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 86 (6.98%)
    0 / 47 (0.00%)
         occurrences all number
    11
    0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    3 / 86 (3.49%)
    0 / 47 (0.00%)
         occurrences all number
    3
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 86 (3.49%)
    0 / 47 (0.00%)
         occurrences all number
    3
    0
    Chills
         subjects affected / exposed
    6 / 86 (6.98%)
    1 / 47 (2.13%)
         occurrences all number
    21
    1
    Influenza like illness
         subjects affected / exposed
    16 / 86 (18.60%)
    2 / 47 (4.26%)
         occurrences all number
    59
    3
    Fatigue
         subjects affected / exposed
    14 / 86 (16.28%)
    7 / 47 (14.89%)
         occurrences all number
    35
    10
    Injection site erythema
         subjects affected / exposed
    18 / 86 (20.93%)
    1 / 47 (2.13%)
         occurrences all number
    31
    1
    Injection site pain
         subjects affected / exposed
    49 / 86 (56.98%)
    1 / 47 (2.13%)
         occurrences all number
    175
    2
    Injection site reaction
         subjects affected / exposed
    12 / 86 (13.95%)
    0 / 47 (0.00%)
         occurrences all number
    42
    0
    Injection site swelling
         subjects affected / exposed
    6 / 86 (6.98%)
    0 / 47 (0.00%)
         occurrences all number
    16
    0
    Malaise
         subjects affected / exposed
    5 / 86 (5.81%)
    0 / 47 (0.00%)
         occurrences all number
    15
    0
    Pain
         subjects affected / exposed
    4 / 86 (4.65%)
    1 / 47 (2.13%)
         occurrences all number
    8
    1
    Pyrexia
         subjects affected / exposed
    35 / 86 (40.70%)
    1 / 47 (2.13%)
         occurrences all number
    132
    5
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 86 (5.81%)
    1 / 47 (2.13%)
         occurrences all number
    11
    1
    Nausea
         subjects affected / exposed
    6 / 86 (6.98%)
    2 / 47 (4.26%)
         occurrences all number
    7
    2
    Stomatitis
         subjects affected / exposed
    0 / 86 (0.00%)
    2 / 47 (4.26%)
         occurrences all number
    0
    2
    Vomiting
         subjects affected / exposed
    3 / 86 (3.49%)
    0 / 47 (0.00%)
         occurrences all number
    7
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 86 (3.49%)
    2 / 47 (4.26%)
         occurrences all number
    3
    2
    Dyspnoea
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 47 (0.00%)
         occurrences all number
    2
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 86 (1.16%)
    2 / 47 (4.26%)
         occurrences all number
    1
    2
    Rash
         subjects affected / exposed
    1 / 86 (1.16%)
    2 / 47 (4.26%)
         occurrences all number
    1
    2
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    3 / 86 (3.49%)
    0 / 47 (0.00%)
         occurrences all number
    3
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    4 / 86 (4.65%)
    0 / 47 (0.00%)
         occurrences all number
    7
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 86 (1.16%)
    2 / 47 (4.26%)
         occurrences all number
    2
    3
    Cystitis
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    2
    Pneumonia
         subjects affected / exposed
    1 / 86 (1.16%)
    1 / 47 (2.13%)
         occurrences all number
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 86 (3.49%)
    2 / 47 (4.26%)
         occurrences all number
    3
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hypercalcaemia
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Sep 2014
    A comprehensive review of the Phase III results, together with all other available clinical and laboratory data with various recombinant proteins tested in different diseases and settings now suggests that the anticancer activity of this technology may well be limited to a subgroup of Stage III melanoma patients with a specific predictive gene signature. A few patients in early metastatic melanoma also appear to benefit from this type of treatment. There is no evidence to believe that the PRAME ASCI can be successful relative to the MAGE-A3 ASCI because: • The PRAME ASCI and MAGE-A3 ASCI are produced from the same technology platform i.e. a recombinant protein adjuvanted with AS15, and both ASCIs share the same theoretical mechanism of action. • The PRAME ASCI has shown similar clinical efficacy in the metastatic melanoma setting compared to MAGE-A3 ASCI. • The PRAME ASCI has a similar immunogenicity profile relative to MAGE-A3 ASCI in the lung adjuvant setting. Consequently, GSK Biologicals has decided to stop further development of recPRAME + AS15 as a standalone treatment for cancer patients. This decision is not motivated by any safety concern as confirmed by the IDMC on 20 June 2014. In light of this decision, no further patients were randomized to the study and enrolled patients not yet treated were not to start their treatment as of 18 July 2014. Primary and secondary objectives will not be assessed as planned. All clinical and safety data collected in the study will be analysed descriptively. By default, for each biological sample already collected in the scope of this study and not tested yet, testing will not be performed except if a scientific rationale remains relevant despite the premature termination of the study. In this case, testing will be done in compliance with the protocol and ICF signed by the patient.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    As of 18 July 2014, the recruitment was stopped and the study was unblinded. For patients randomized to the placebo group, no further protocol visits were to be performed except for the concluding visit and no further doses were to be administered.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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